[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Page 942-943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.

[[Page 943]]

    Name of Committee: Pediatric Oncology Subcommittee of the Oncologic 
Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held March 14, 2006, from 8 a.m. 
to 5 p.m.
    Location: Gaithersburg Hilton, The Ballrooms, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Johanna M. Clifford, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 
20857, 301-827-7001, FAX: 301-827-6776, e-mail: cliffordj@cder.fda.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512542. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The subcommittee will discuss the following: (1) Clinical 
studies of methotrexate and daunomycin to be conducted under the Best 
Pharmaceuticals for Children Act; (2) phase 4 requirements for 
Deferasirox, Norvartis Pharmaceuticals, as mandated under accelerated 
approval; and (3) the Center for Drug Evaluation and Research's process 
for handling drug shortages. The background material will become 
available no later than the day before the meeting and will be posted 
on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm 

under the heading ``Oncologic Drugs Advisory Committee; Pediatric 
Oncology'' (click on the year 2006 and scroll down to the previously 
named committee).
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person by March 7, 2006. 
Oral presentations from the public will be scheduled between 
approximately 2 p.m. to 3 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before March 7, 2006, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Johanna M. Clifford 
at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E5-8332 Filed 1-5-06; 8:45 am]